Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No patients were enrolled in Group 10, recurrent or refractory retinoblastoma.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Group 1 - Recurrent or Refractory Hepatoblastoma

Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 2 - Recurrent or Refractory Synovial Sarcoma

Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 3 - Recurrent or Refractory Rhabdomyosarcoma

Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 4-Recurrent or Refractory Adrenocortical Carcinoma

Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease

Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 7-Neuroblastoma With Measurable Disease

Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 8 - Recurrent Osteosarcoma

Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 9 - Recurrent or Refractory Wilms Tumor

Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 10 - Recurrent or Refractory Retinoblastoma

Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Group 10, Recurrent or Refractory Retinoblastoma no patients were enrolled.

Reporting Groups

Description

Group 1 - Recurrent or Refractory Hepatoblastoma

Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 2 - Recurrent or Refractory Synovial Sarcoma

Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 3 - Recurrent or Refractory Rhabdomyosarcoma

Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 4-Recurrent or Refractory Adrenocortical Carcinoma

Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease

Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Grp 7-Neuroblastoma With Measurable Disease

Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 8 - Recurrent Osteosarcoma

Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 9 - Recurrent or Refractory Wilms Tumor

Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

laboratory biomarker analysis: Correlative studies

Group 10 - Recurrent or Refractory Retinoblastoma

Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.